Inclusion of Pregnant and Lactating Persons in Clinical Trials Proceedings of a Workshop (2023) / Chapter Skim
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7 A Path Toward Inclusion
7 A Path Toward Inclusion
Pages 79-88
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From page 79... ...
(Bianchi) • Stakeholders need to work together to change the research culture and advocate for the thoughtful inclusion of pregnant and lactating persons in clinical trials.
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From page 80... ...
people through research instead of from research." A theme across the task force's recommendations is the need to "change the existing culture that has limited scientific knowledge of therapeutic product safety, effectiveness, and dosing for pregnant and lactating people." She highlighted several key recommendations including recommendations to remove pregnant persons as a vulnerable population under the Common Rule; expand the workforce of clinicians and researchers with expertise in obstetric and lactation pharmacology and therapeutics; remove the regula tory barriers; and referring participants to the PRGLAC Task Force website for the full set of recommendations and the implementation report.2 Implementation of PRGLAC Task Force Recommendations Bianchi reviewed the progress made thus far in implementing the PRGLAC Task Force recommendations (summarized in Box 7-1)
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From page 81... ...
Recommendation 7: Reduce liability to facilitate an evidence base for new therapeutic products that may be used by women who are, or may become, pregnant and by lactating women. Actions • Congressionally mandated study with the National Academies to convene a panel with specific legal, ethical, regulatory, and policy expertise to develop a framework for addressing medicolegal and liability issues when planning or conducting research specific to pregnant people and lactating people.
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From page 82... ...
• Researchers in NICHD's Global Network for Women's and Children's Health Research, in collaboration with the Bill & Melinda Gates Foundation, will as sess whether a single oral dose of the antibiotic azithromycin during labor reduces the risk of maternal and infant bacterial infection and death in seven low- and middle-income countries. • NICHD has open grant solicitations on "Translational Research in Maternal and Pediatric Pharmacology and Therapeutics" encouraging proposals that address the PRGLAC Task Force recommendations.
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From page 83... ...
Recommendation 10, calling for the implementation of "a proactive approach to protocol development and study design to include pregnant women and lactating women in clinical research," has resulted in several initiatives. As mentioned, the International Maternal, Pediatric, Adolescent AIDS Clinical Trials (IMPAACT)
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From page 84... ...
Opportunities for Future Action Bianchi discussed additional areas covered by the PRGLAC Task Force recommendations and the implementation plan for which action is still needed. With regard to removing regulatory barriers (recommendation 4)
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From page 85... ...
PATHWAYS FORWARD The inclusion of pregnant people in research is both a public health issue and reproductive justice issue, Leslie Meltzer Henry, University of Maryland Carey School of Law, said. Legal concerns can be addressed, and lawyers knowledgeable in this area can advise stakeholders on developing creative risk management strategies that can help enable these studies, and she mentioned several opportunities to address obstacles.
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From page 86... ...
Planned Parenthood decisions. The workshop discussions took place in the context of the anticipated decision based on the leaked draft opinion by Justice Samuel Alito.
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From page 87... ...
Although there have been intensive efforts in recent years to increase the inclusion of pregnant and lactating persons in clinical trials, pregnant and lactating persons were still excluded from the initial COVID-19 vaccine clinical trials. Nevertheless, many groups have come together in recent years around the crucial need to improve representation of pregnant and lactating persons in clinical trials, including NIH, FDA, industry, clinicians, academic researchers, the National Academies, and pregnant and lactating persons themselves.
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